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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK

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LASIK Back to Search Results
Event Date 01/02/2006
Event Type  Injury  
Event Description

I underwent lasik eye surgery in 2006. Since the surgery, i have suffered from a number of severe complications, and my vision is now permanently damaged. My vision problems, since the surgery, none of which were pre-existing include double vision, halos and starbursts on any light source in a low-light situation, significantly reduced contrast sensitivity - especially in low-light situations-, and chronic headaches from eye strain. The surgery was performed by a dr. Follow-up surgeries were performed on each eye in a failed attempt to correct my problems. After dealing with these issues for two years, i was instructed by the doctor to simply wait for them to clear up, which still hasn't happened -it's now been more than four years since the original surgery-. I finally gave up on trying to convince dr and his staff that i had significant vision problems; they seemed convinced that it was either all in my head or something that would resolve itself eventually.

 
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Brand NameNA
Type of DeviceLASIK
MDR Report Key1577588
Report NumberMW5014290
Device Sequence Number1
Product CodeLZS
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/09/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/09/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Service Personnel
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 01/09/2010 Patient Sequence Number: 1
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